An observational study in End-stage Renal Disease, sponsored by Medtronic Endovascular. Completed at 5 sites in Germany. Per ClinicalTrials.gov, last updated 2021-02-08.
Sponsored by Medtronic Endovascular · Observational
Ellipsys Vascular Access System Registry will enroll up to 100 patients to evaluate the use and performance of the Ellipsys Vascular Access System when it is used within its intended use in accordance with standard of care in a clinical setting. The Ellipsys Vascular Access System is intended for use to create an arteriovenous (AV) fistula via percutaneous access.
Ellipsys Vascular Access System Registry is a non-randomized, prospective, post-market, multi-center registry of the Ellipsys Vascular Access System in which up to 100 patients will be enrolled to evaluate the use and performance of the Ellipsys Vascular Access System when it is used within its intended use in accordance with standard of care in a clinical setting. The Ellipsys Vascular Access System is intended for use to create an AV fistula via percutaneous access. The primary performance endpoint is Clinical Success at the 90-day endpoint, where Clinical Success is defined as an access site that achieves a venous diameter of greater than or equal to 4 mm and blood flow greater than or equal to 500 ml/min in the brachial artery as measured via duplex ultrasound.
Patients with End-Stage Renal Disease or chronic kidney disease who provide written informed consent; who are currently require dialysis or it is anticipated will need dialysis within six months of enrollment; who meet all inclusion criteria and none of the exclusion criteria; and who are considered eligible for enrollment.
Patients deemed medically eligible for upper extremity autogenous AV fistula creation, per institutional guidelines and/or clinical judgment Adequate quality vein base on pre-operative assessment:
Adequate quality artery base on pre-operative assessment:
Exclusion Criteria:
The Ellipsys Vascular Access System comprises the Ellipsys Catheter, Ellipsys Crossing Needle and Ellipsys Power Controller. The Ellipsys Crossing Needle is used to facilitate access between the artery and the vein. The Ellipsys Catheter is placed percutaneously into the selected vein in close proximity to the selected artery. The Ellipsys Catheter is actuated at the selected anastomosis site, and the vein and artery are approximated. Once the vessels are in the appropriate relative positions the catheter is connected to the Ellipsys Power Controller to create the anastomosis after which the Ellipsys Catheter is removed, and the access site is closed using standard percutaneous closure techniques.
The number of patients with a vascular access site that achieves a venous diameter of greater than or equal to 4 mm and blood flow greater than or equal to 500 ml/min in the brachial artery as measured via duplex ultrasound.
Primary endpoint
Time frame: 90 days
Percent of Ellipsys Vascular Access procedures that successfully create an arteriovenous fistula (AVF) excluding Access Failures.
Device Success Rate
Time frame: 12 months
The length of time until a patient is able to undergo 2-needle cannulation for dialysis OR access vessel has a diameter ≥ 6 mm and a mean flow rate of ≥ 600 ml/min if the patient is not undergoing dialysis.
Time to Functional Patency
Time frame: 12 months
Percent of patients that require dialysis and sustain 3 consecutive 2-needle cannulations at the prescribed needle gauge and blood flow rate.
Dialysis Rate
Time frame: 12 months
The number of surgical or endovascular interventions required to achieve or maintain Functional Patency.
Secondary Procedure Rate
Time frame: 12 months
Number of patients with patency defined as an anastomosis that has flow whether it is being used for dialysis or not.
Arterio-venous fistula patency
Time frame: 12 months
Length of time from initial access creation to achieve Functional Patency or to time of abandonment of AVF.
Cumulative patency
Time frame: 12 months
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Medtronic Endovascular